Giuliani Pharma Spa and Ethical eClinical Solutions

Born in 1889, Giuliani Pharmaceuticals has been working for years on gastroenterology research and development, achieving groundbreaking results identifying possible new approaches in the treatment of inflammatory bowel diseases.

The research has generated projects developing new chemical or biotechnology-derived products (i.e. GED projects in the R&D pipeline).

CHORUS® the e-Crf® multi study portal

The E-CRF customized for Giuliani is currently a multi-study and multi-project platform where many studies coexist in their segregated environments.

Every project is accessible by its own set of authorized users, with the study specific profiles (Investigators, Data Entry users, CRAs, Data and Project managers, Sponsor) which grants are designed for the study specific protocol specifications.

Every project hosted in the E-CRF platform can exploit the common functions and services of the platform:

authentication

documentation

help desk

27001 infra-structure

Validation (GAMP 5, CRF21 part 11) documentation package

Every project requires taylored software packages and functions:

CTMS

Randomize

Different data capturing packages (Remote Data Entry, Double Blind Data Entry or data import from legacy or third party platforms)

Data Cleaning & Queries

Report & Data Export

Safety DB

E-Data Room

SAFETY DB ® Safety Database Management

The SAFETY DB software package for Giuliani has been developed for the Pharmacovigilance Surveillance of the post-marketing effects of the products and results of the clinical trials and research activities conducted by Giuliani Pharma S.p.A.

Safety DB records and stores adverse events notification and all the collected information about the patients' history and reactions, aiding the in charge QPPV (Qualified Person for Pharmacovigilance) in the communication of the data to the Pharmacovigilance authorities.

E-Data Room® Virtual Data Room

Giuliani Pharma S.p.A. uses the dedicated E-Data Room safe file system with the purpose of allowing access and documentation management features to users located remotely from Giuliani headquarter with the correctly assigned grants (view / download / print) only to the assigned folders and files.